The primary focus of this role is to evaluate the purification processes of novel biopharmaceutical molecules, with substantial involvement in both upstream and downstream activities.
- Upstream Responsibilities: Conduct CHO cell culture experiments to evaluate expressability, chain balance, and bispecific antibody assembly. This includes assessing various aspects of cell culture that impact molecule production quality and efficiency.
- Downstream Responsibilities: Execute column chromatography to assess bispecific manufacturability, utilizing impurity mapping techniques to evaluate the separation of product-related variants and optimize purification processes.
- Analytical Assessment: Apply orthogonal assays to evaluate bioprocess outcomes, with a focus on ensuring product quality. Analyze results to support product optimization and process improvements.
Education, Experience, and Qualifications:
- Bachelor’s degree or equivalent in Biochemistry, Biotechnology, or a related discipline.
- 4-8 years of experience in the biopharmaceutical or related protein sciences industry.
- Experience contributing to IND-enabling manufacturing processes, supporting both toxicology and clinical phases.
Core Competencies and Skills:
- Downstream Purification Expertise: Extensive experience in column chromatography using Akta/Unicorn systems, with a strong background in a range of column chemistries (affinity, ion exchange, hydrophobic interaction, multimodal) and operational modes
- Upstream Cell Culture Proficiency: Skilled in CHO cell expression, including both transient and stable methods. Proficient in sterile techniques, cell passaging, transfection, and harvest recovery.
- Product Quality Analysis: Competence in applying orthogonal analytical assays, including U/HPLC for sizing and reversed-phase, mass spectrometry, and capillary electrophoresis, to characterize product-related variants and ensure product integrity.